(13 days)
The WBR Half Dose is indicated for the acquisition, formatting and storage of scintigraphy camera output data. It is capable of processing and displaying the acquired information in traditional formats, as well as in pseudo three dimensional renderings, and in various forms of animated sequences, showing kinetic attributes of the image organs.
The WBR Half dose is a modification of labeling of the legally marketed device. The device is an image processing system, which is interfaced to gamma cameras, processes the cameras' acquired data utilizing parallel and non - parallel beams and produce high resolution images. The images can be transfered to any other PACS device, which is DICOM or Interfile compatible. The modified labeling claims that, as far as the acquired information density is maintained. the same image quality is achieved either by fast acquisition or by reduced dose acquisition modes.
The provided text is a 510(k) summary for the WBR Half Dose device, which is an image processing system for gamma cameras. It primarily focuses on the regulatory aspects, device description, and substantial equivalence to a predicate device.
Crucially, the document does NOT contain a detailed study report with specific acceptance criteria, device performance metrics, sample sizes, expert qualifications, or ground truth establishment relevant to the device's image processing claims.
The safety and effectiveness section vaguely states: "Bench and clinical data demonstrate that reconstructed images are equivalent or of better resolution comparing to images that are reconstructed by filter back projection. No adverse affects have been detected." This is a general statement and not a detailed study.
Therefore, most of the requested information cannot be extracted from the provided text.
Here is what can be inferred or explicitly stated based on the text, with clear indications of missing information:
Acceptance Criteria and Device Performance
The document does not explicitly define acceptance criteria in a quantitative manner. The closest statement regarding performance is a qualitative claim of equivalence or improvement:
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Reconstructed images must be equivalent or of better resolution compared to images reconstructed by traditional filter back projection. | Reconstructed images are equivalent or of better resolution compared to images reconstructed by filter back projection. |
| No adverse effects detected. | No adverse effects have been detected. |
Detailed Study Information (Much of this information is missing from the provided text)
-
Sample size used for the test set and the data provenance:
- Sample size: Not specified in the document. The text only mentions "Bench and clinical data."
- Data provenance: Not specified (e.g., country of origin, retrospective or prospective).
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of experts: Not specified.
- Qualifications of experts: Not specified.
-
Adjudication method for the test set:
- Not specified.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- The document does not mention an MRMC study. The device is primarily an "image processing system" that claims "high resolution images" and "equivalent or of better resolution." It's not described as an AI-assisted diagnostic tool for human readers, but rather a system for generating images. Therefore, the concept of "human readers improve with AI vs without AI assistance" as typically understood in MRMC studies for diagnostic AI, does not directly apply to this device's description.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The claims around "equivalent or of better resolution" could imply a standalone evaluation of image quality, but the specifics of how this was measured (e.g., against a reference standard or objective metrics) and whether human interpretation was completely excluded from the evaluation are not provided. The device itself is an algorithm only in the sense that it processes data to produce images without direct human intervention in the processing step.
-
The type of ground truth used:
- Not specified. Given the claim is about "resolution," the ground truth would likely relate to objective image quality metrics or potentially human perception of image quality. Pathology or outcomes data are typically used for diagnostic accuracy claims, which are not the primary focus here.
-
The sample size for the training set:
- Not applicable/Not specified. The document describes a "Special 510(k) Submission" for a "modification of labeling of the legally marketed device." It's an "image processing system," and while such systems involve algorithms, the text does not indicate that it uses machine learning/AI models that require a separate "training set" in the modern sense. It implies traditional image reconstruction algorithms.
-
How the ground truth for the training set was established:
- Not applicable/Not specified, as a "training set" in the context of modern machine learning is not explicitly mentioned or implied. If it refers to data used for algorithm development/tuning, the method for establishing ground truth for such data is not provided.
{0}------------------------------------------------
510(k) Summary of Safety and Effectiveness (in accordance to 21 CFR 807.87(h))
Device Name
Proprietary Device Name: WBR Half Dose.
Establishment Name
UltraSPECT Ltd.
APR - 2 2008
Submission contact person: Dan Laor Sireni 6, Haifa 32972, Israel TEL: 972-4-8246632
Device Classification
Product Code: Subsequent Product Code CFR section: Panel Identification: Device Description: Classification:
KPS LLZ 892.1200 Radiology Emission computed tomography system Class II Product
Reason for 510(k) Submission
Special 510(k) Submission
Identification of Legally Marketed Equivalent Devices
WBR Xact.cardiac & Xpress.cardiac - K050815
Device Description
The WBR Half dose is a modification of labeling of the legally marketed device. The device is an image processing system, which is interfaced to gamma cameras, processes the cameras' acquired data utilizing parallel and non - parallel beams and produce high resolution images. The images can be transfered to any other PACS device, which is DICOM or Interfile compatible. The modified labeling claims that, as far as the acquired information density is maintained. the same image quality is achieved either by fast acquisition or by reduced dose acquisition modes.
Intended Use of Device
The WBR Half dose is indicated for the acquisition, formatting and storage of scintigraphy camera output data. It is capable of processing and displaying the acquired information in traditional formats, as well as in pseudo three dimensional renderings, and in various forms of animated sequences, showing kinetic attributes of the image organs
Safety & Effectiveness
The device has been designed, verified and validated complying to 21CFR 820.30 regulations. Bench and clinical data demonstrate that reconstructed images are equivalent or of better resolution comparing to images that are reconstructed by filter back projection. No adverse affects have been detected.
Substantial Equivalency
It is UltraSPECT's opinion that the WBR Half Dose and the Xact.cardiac & Xpress.cardiac are substantially equivalent in terms of safety and effectiveness to the above rredicated aviace.
{1}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle with three wings, representing health, human services, and the well-being of the American people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
UltraSPECT Ltd. % Mr. Dan Laor Regulatory Consultant Sireni 6 Haifa 32972 ISRAEL
Re: K080784
Trade/Device Name: WBR Half Dose Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS Dated: March 9, 2008 Received: March 20, 2008
Dear Mr. Laor:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your I epp. o targe can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the federal Register.
Image /page/1/Picture/10 description: The image is a circular logo with the text "1906-2006" at the top. Below the text is the acronym "FDA" in large, bold letters. Underneath the acronym, the word "Centennial" is written in a cursive font. The logo appears to be a commemorative emblem for the centennial anniversary of the FDA.
Protecting and Promoting Public Health
{2}------------------------------------------------
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act . or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally. marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon . Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
ાં ર
Enclosure
{3}------------------------------------------------
Indications for Use
510(k) Number (if known):
Device Name: WBR Half Dose
Indications For Use:
The WBR Half Dose is indicated for the acquisition, formatting and storage of scintigraphy camera output data. It is capable of processing and displaying the acquired information in traditional formats, as well as in pseudo three dimensional renderings, and in various forms of animated sequences, showing kinetic attributes of the image organs.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of
Norma M. White
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device 510(k) Number
§ 892.1200 Emission computed tomography system.
(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.